Patricia Van Arnum

High-containment manufacturing, whether for an active pharmaceutical ingredient or finished drug product, requires specialized approaches in facility design, equipment selection, and manufacturing processes to achieve the desired levels of containment and minimize operator exposure. As with pharmaceutical manufacturing overall, science- and risk-based approaches to reach those goals serve as a crucial framework for optimizing high-potency manufacturing as well for specific elements in the process.

This article was also published in our US sister publication 

Articles

Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.

Optimising High-Potency Manufacture

At the opening session of the annual meeting and exposition of the American Association of Pharmaceutical Scientists’ (AAPS, Arlington, VA, 

), AAPS President Jay Sisco presented ten achievement awards and 24 AAPS fellowships recognizing professional contributions to the pharmaceutical sciences. 

 were among those recognized. (EAB member 

Dr. Hussain, vice-president and global head of biopharmaceutical development at Sandoz, (

AAPS Achievement Award in Regulatory Sciences

. He was recognized for performing pioneering research in pharmaceutical applications of artificial neural networks (formulation design and pharmacokinetics) and for his scientific and regulatory leadership in several key initiatives at the US Food and Drug Administration (Rockville, MD, 

). These include the Product Quality Research Institute and science-based policies (FDA and ICH guidelines) in the areas of bioavailability and bioequivalence and quality, as well as the Process Analytical Technology initiative. 

Dr. DeLuca, professor, College of Pharmacy, University of Kentucky (

Dale E. Wurster Research Award in Pharmaceutics

 in recognition of his substantial contributions in inducing thermal transitions during the lyophilization process, improving cycles through the addition of mass-transfer accelerators, and allowing formulation of biopharmaceuticals through the use of cryoprotectants. 

, who was the Burroughs-Wellcome Professor of Pharmaceutics and director of Industrial Pharmacy Research at the Philadelphia College of Pharmacy, University of the Sciences in Philadelphia (

), for his contributions to his students and the pharmaceutical sciences. 

 Research Achievement Award in Analysis and Pharmaceutical Quality

, senior research fellow at Bristol-Myers Squibb Pharmaceutical Research Institute (

) for his contributions to bioanalytical sciences and pharmaceutical analysis.

, founder and CEO of the Institute for OneWorld Health (

), the first nonprofit pharmaceutical company in the United States. Its purpose is to develop safe, effective, and affordable medicines for people with neglected diseases in the developing world. Earlier this week, the institute was awarded a grant of $46 million from the Bill & Melinda Gates Foundation to expand its research on new treatments to complement traditional approaches for fighting diarrhea. That announcement was made at Forum 10, the Global Forum for Health Research’s annual meeting in Cairo.

) for his role in supporting the approval of several major, new drugs, streamlining the drug development process, raising the standard of practice of the pharmaceutical sciences in developing nations, and providing financial support for students interested in the pharmaceutical sciences.

, associate professor and vice-chair of the Department of Pharmaceutical Science at the University of Kentucky. His research focuses on the use of nanotechnology to engineer small nanometer-sized particles and on methods to engineer lipids used in drug delivery.

 New Investigator Grant in Pharmaceutics and the Pharmaceutical Technologies

), where she is focusing on pharmaceutical granulation to understand the underlying science and physics, including the nucleation and granulation of hydrophobic drugs. 

 Research and Achievement Award in Drug Design and Discovery 

 for his research on developing the dopamine transporter-selective 3-phenyltropane analog RTI-336 to treat cocaine abuse and the selective kappa opioid receptor antagonist JDTic to prevent cocaine-use relapse.

 Research Achievement Award in Pharmacokinetics, Pharmacodynamics, and Drug Metabolism

, professor and chair of biopharmaceutical sciences at the University of California, San Francisco (

) for research on the pharmacogenomics of membrane transporters. 

AAPS recognized 24 researchers as 2006 AAPS Fellows for scholarly and research contributions to the pharmaceutical sciences such as original articles, scientific presentations at AAPS Annual Meetings, and patents: 

, a polymer chemist, chemical engineer and pharmaceutical scientist, whose expertise covers the syntheses of novel smart and bioactive polymers, stimuli-responsive drug delivery, cell-function control and encapsulation, engineering nanosystems for overcoming cancer medical device reporting and tumor extracellular pH targeting, and stabilization and delivery of proteins and genetic materials. 

for his research on polymeric microparticulate and lipid-based drug delivery systems as well as the strategy of covalently linking monoclonal antibodies to colloidal carriers for drug targeting. 

for work on mass spectrometric methods for the quantitation and elucidation of structures of endogenous biomolecules, DNA-adducts, protein-adducts, drugs and their metabolites. He is currently the A.N. Richards Professor and vice-chair of Pharmacology in the School of Medicine, a professor of chemistry in the School of Arts and Sciences, and director of the Center for Cancer Pharmacology at the University of Pennsylvania (

 for research focused on the discovery and development of novel antiviral and anticancer therapies, which included characterizing the preclinical pharmacokinetics of approximately 40 new potential antiviral or anticancer compounds. He is dean of the graduate school and professor of pharmaceutics in the School of Pharmacy at Virginia Commonwealth University (

for research on colloid and interfacial chemistry and its application to drug and gene delivery and work on microsphere, nanoparticle, liposome, emulsion, and hydrogel formulations. Dr. Burgess is a past president of AAPS.

 for interdisciplinary research in the area of therapeutic aerosols for inhalation.  His research ranges from the 

 production methods and characterization of pharmaceutical aerosols, to the 

imaging study of deposition in the lungs after inhalation.  

, president and CEO of Chrai Associates Inc. With over 25 years of experience in the pharmaceutical and biotechnology industries, which included positions with Schering-Plough Corporation (

), and The Liposome Company, Dr. Chrai was recognized for being instrumental in developing clean-in-place and sterilize-in-place systems for parenteral manufacturing. This advance led to the good manufacturing practices guidelines for sterilization-in-place and depyrogenation–by–dilution, and enhanced the sterility assurance of parenteral products. His work in clean-in-place technology led to the reduction of cross contamination in pharmaceutical operations.

for his research on non-steroidal androgens, He is vice-president of preclinical research and development at GTx, Inc. (

) and a professor of pharmaceutics in the College of Pharmacy at Ohio State University (

for his work in drug delivery, formulation, analytical method development and process science, which contributed to the approval of several drugs. He is vice-president of pharmaceutical operations for Omeros Corporation (

for his research concentrates on mechanistic studies of neurotransmitters and drugs affecting them in the central nervous system. He is a professor of medicinal chemistry at the University of Kansas (

for  developing combinatorial chemistry approaches, including the "tea bag" for the synthesis of individual compounds and positional scanning deconvolution of mixture-based libraries.

, for his contributions in novel methods development such as good systems practice method. He is a professor of pharmacokinetics and pharmacodynamics and dean of the National Defense Medical Center in Taiwan.

for pioneering the use of radiochemical techniques to study pharmaceutical systems. He is professor of pharmaceutical sciences in the College of Pharmacy at the University of Kentucky and has served as the director of the Center for Pharmaceutical Science & Technology since 1998. 

 for his research pharmacokinetic and pharmacodynamic determinants. He is global head of clinical pharmacology at Pfizer, Inc. (

 for developing receptor-selective opioid ligands and elucidating the key ligand-receptor recognition features that underlie selectivity. He is professor of medicinal chemistry and associate dean for research in the College of Pharmacy of the University of Michigan (

 for work on drug solubility and safety problems using a nanotechnology-based targeted drug delivery approach. 

for research in the field of drug metabolism and transport.

for his work in drug transport proteins and their role in pharmacokinetics and pharmacodynamics. He is currently senior director of pharmacology at Sunesis Pharmaceuticals, Inc. (

 for research focusing on understanding why many drugs cause unpredictable skin rashes in patients, particularly in patients with AIDS.  He is dean of the College of Pharmacy, Nursing, and Health Sciences at Purdue University (

for work in drug delivery using the prodrug approach, pharmacokinetic and pharmacodynamic modeling, and nasal delivery of drugs for systemic absorption. He is currently director of global regulatory affairs at Merck & Co., Inc (

 for scientific contributions n the areas of biomarkers and surrogate endpoints, experimental medicine, pharmacokinetics, pharmacodynamics, and drug-drug interactions across a variety of therapeutic areas. He is executive director, clinical pharmacology at Merck & Co., Inc. 

 for developing novel formulation approaches for proteins and peptides. He is currently with the formulation group at Genentech,  Inc. (

for work in understanding how lipids and lipoproteins modify the pharmacokinetics and biological activity of water-insoluble drugs, which has increased the understanding of the mechanisms involved in plasma distribution of hydrophobic drugs. He is a professor, distinguished university scholar, and chair of pharmaceutics at the University of British Columbia (

, for work in understanding the rational development and clinical potential of delivering anti-fungal drugs, including the use of nanoparticulate forms of drugs. He is the Johnson & Johnson Centennial Professor in Pharmaceutics at the University of Texas at Austin (

AAPS, San Antonio (Oct. 29)-At the opening session of the annual meeting and exposition of the American Association of Pharmaceutical Scientists' AAPS President Jay Sisco presented ten achievement awards and 24 AAPS fellowships recognizing professional contributions to the pharmaceutical sciences.